Global Clinical Label Designer & Reviewer

BioSpace; North Chicago (IL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Paid time off & holidays

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking an experienced clinical labeling expert to independently design, review, and approve study-specific label content for global studies. This Grade 12 role integrates hands-on label design with independent review and approval accountabilities, and has broad global scope with no direct reports.

The position requires collaboration with Regulatory Affairs, Quality Assurance, and regional affiliates to ensure compliant labeling across the United States, EU, JAPAC, and other countries.

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience.
• Experience in clinical label design, clinical supply, or regulated GxP environments; ability to work globally and independently.
• Knowledge of GMP/cGMP, CFR, EU Annex 13, and ICH principles.
• Strong analytical, organizational, and communication skills with ability to manage multiple studies.

Responsibilities

• Review global clinical label requirements and coordinate with Clinical Supply Project Managers.
• Create, design, review, and approve study-specific and global label templates within the system.
• Ensure label text and approvals comply with GMP/cGMP and global regulations (US, EU, JAPAC).
• Obtain and document required approvals from Regulatory Affairs, QA, and regional affiliates; resolve conflicts.
• Maintain global label phrase library; conduct annual reviews and changes.
• Update regulatory requirements in partnership with labeling leadership and regulatory stakeholders.
• Coordinate with third-party label vendors on orders, proofs, and quality expectations.
• Review label and inventory impacts; support resupply decisions and destruction requests.
• Manage multiple studies with independent judgment and on-time delivery.
• Collaborate to improve labeling processes and support team goals.

Skills

Clinical labeling

Global regulatory labeling

GxP experience

Project management

Independent judgment

Education

Bachelor’s degree

Tools

Validated label design system

Phrase library management

Vendor coordination

Job description

AbbVie is seeking an experienced clinical labeling expert to independently design, review, and approve study-specific label content for global studies. This Grade 12 role integrates hands-on label design with independent review and approval accountabilities, and has broad global scope with no direct reports.

The position requires collaboration with Regulatory Affairs, Quality Assurance, and regional affiliates to ensure compliant labeling across the United States, EU, JAPAC, and other countries.